MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP CRYOCONSOLE; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	106A3
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event summary: a repair service visit took place for the high baseline flow.For the pt6 pressure transducer visual inspection, results showed that the product was intact with no apparent issues.Assembled to universal console and following a warm up time of thirty minutes, the console was tested along with a test catheter and passed the performance test without any issue.During the pt6 verification test, the pt6 was able to be alerted as expected.Pt6 pressure transducer passed the performance test as per specification.The console 106a3 / n6336, has not been returned for investigation and is still in use.The reported issue does not indicate a console manufacturing related defect.In conclusion, the reported triggering of the baseline flow icon issue was not confirmed neither through the data analysis nor through testing.The pt6 pressure transducer passed the performance test as per specification.Console is still in use after the replacement of pt6 with no further issues detected with console.The product issue reported (baseline flow icon) is not likely to cause or contribute to a death or serious injury; however, the risk of the patient being under general anesthesia without full therapeutic effect is the adverse event being reported.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a cryo ablation procedure, a baseline flow icon was seen at the beginning of a case.The coaxial umbilical cable was replaced without resolution.The flow value was out of tolerance.The electrical umbilical cable and coaxial umbilical cable were disconnected without resolution.The system was rebooted, and a system notice was received indicating that the safety system detected a compromised outer vacuum.Then, the electrical umbilical cable was disconnected and reconnected again, and the system notice resolved.The baseline flow icon was still present, and the flow was out of tolerance.The case was aborted while the patient was under general anesthesia.No patient complications have been reported as a result of this event.A field service visit took place at a later date and the high baseline flow was resolved when the flow meter was zeroed.

• Brand Name: CRYOCONSOLE
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• MDR Report Key: 8002005
• Report Number: 3002648230-2018-00752
• Device Sequence Number: 1190186
• Product Code: LPB
• UDI-Device Identifier: 00613994775955
• UDI-Public: 00613994775955
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2013
• Device Model Number: 106A3
• Device Catalogue Number: 106A3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other